Devices › Gas-machine, anesthesia
Device brand name · Anesthesia gas machine
Aestiva 7100: medical device reports filed with FDA
871 reports name it, 2014–2024. Manufacturer given most often on reports: Datex-Ohmeda. Product code BSZ.
- 871
- device reports naming the brand
- 0% of all MAUDE reports · about 70 a year
- 0
- reports, 12 months to August 2026
- 10 in the 12 months before
- 99.5%
- classified as malfunction
- 97.9% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 871 reports that name the brand "Aestiva 7100" (anesthesia gas machine), received between February 2014 and December 2024; the manufacturer given most often on reports is Datex-Ohmeda. Spellings of one product vary from report to report.
0 reports arrived in the 12 months to August 2026, against 10 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (99.5%) and injury (0.3%); across all gas-machine, anesthesia reports (product code BSZ) death is recorded in 0.2% and malfunction in 97.9%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are therapeutic or diagnostic output failure (16%), mechanical problem (12.5%) and device operates differently than expected (9.6%). The patient problems coded most often are no patient involvement, metal related pathology and pulmonary edema. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 48,583 reports carrying product code BSZ. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Therapeutic or diagnostic output failure | 139 | 16% | 14.7% |
| Mechanical problema mechanical problem | 109 | 12.5% | 9.9% |
| Device operates differently than expectedthe device behaved unexpectedly | 84 | 9.6% | 3.7% |
| Device alarm system | 52 | 6% | 1.5% |
| Failure to run on battery | 43 | 4.9% | 8.3% |
| Unexpected shutdown | 30 | 3.4% | 2% |
| Gas/air leak | 29 | 3.3% | 2.7% |
| Leak/splashthe device leaked | 28 | 3.2% | 1.6% |
| Device displays incorrect message | 25 | 2.9% | 1.8% |
| No display/image | 21 | 2.4% | 3.7% |
| Output problem | 21 | 2.4% | 2.7% |
| Unexpected therapeutic results | 19 | 2.2% | 3% |
| Infusion or flow problema problem with flow or infusion | 17 | 2% | 1.7% |
| Pressure problem | 17 | 2% | 1.3% |
| Tidal volume fluctuations | 17 | 2% | 0.5% |
| Inappropriate or unexpected reset | 14 | 1.6% | 0.5% |
| Increase in pressure | 14 | 1.6% | 2.3% |
| Power problem | 14 | 1.6% | 3.5% |
| Breakthe device broke | 13 | 1.5% | 0.9% |
| Device inoperablethe device could not be used | 13 | 1.5% | 0.6% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| No patient involvement | 381 | 43.7% |
| Metal related pathology | 1 | 0.1% |
| Pulmonary edema | 1 | 0.1% |
| Suture abrasion | 1 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Aestiva 7100 | Product code BSZ | All MAUDE reports |
|---|---|---|---|
| Reports | 871 | 48,583 | 26,136,888 |
| Share of that pool | — | 1.8% | 0% |
| Classified as death, per 1,000 reports | 0 | 2 | 9 |
| Classified as injury | 0.3% | 1.5% | 36.2% |
| Classified as malfunction | 99.5% | 97.9% | 62.3% |
| Filed by the manufacturer | 100% | 98% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code BSZ
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Carestation 650 | 6,160 | 1,686 | 0% |
| Avance | 5,977 | 1,353 | 0.1% |
| Aisys | 5,275 | 1,531 | 0.1% |
| Carestation 620 | 4,356 | 1,402 | 0% |
| Aisys Cs2 | 3,105 | 4 | 0.1% |
| Avance Cs2 | 2,945 | 3 | 0.2% |
| Aespire 7100 | 2,778 | 3 | 0.1% |
| Carestation 750 | 2,541 | 1,042 | 0% |
| Aespire 7900 | 2,049 | 11 | 0.2% |
| Aespire View | 1,729 | 10 | 0.1% |
| Aespire | 1,363 | 564 | 0.1% |
| Aestiva 7900 | 2,521 | 2 | 0% |
| Aestiva | 794 | 329 | 0.1% |
| Flow-I | 582 | 0 | 0% |
| Carestation 650 A1 | 479 | 10 | 0% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Aestiva 7100 reports
How many FDA reports name Aestiva 7100?
871 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
malfunction (99.5%) and injury (0.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
therapeutic or diagnostic output failure (16%), mechanical problem (12.5%), device operates differently than expected (9.6%), device alarm system (6%) and failure to run on battery (4.9%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Aestiva 7100 was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.